On 15 July 2024, Bristol-Myers Squibb Company and its subsidiary Receptos LLC filed a patent infringement action in the District of Delaware against Apotex, Inc., the Canadian generic pharmaceutical manufacturer. The suit centred on US11680050B2 — an application-number patent covering capsule formulations of ozanimod at doses of 0.23 mg, 0.46 mg, and 0.92 mg, the active ingredient in BMS’s branded S1P receptor modulator Zeposia®, approved for relapsing multiple sclerosis and moderately to severely active ulcerative colitis. The filing is consistent with Hatch-Waxman ANDA litigation, in which brand manufacturers assert Orange Book-listed patents in response to a generic applicant’s Paragraph IV certification.

The case closed on 12 November 2025 when Judge Gregory B. Williams signed a termination order based on a stipulation of dismissal (Dkt. 22) filed jointly by both plaintiffs. The order reads ‘SO ORDERED’ on the stipulation, with the civil case formally terminated. Critically, the basis of termination is recorded as ‘Case Dismissed,’ but the public record does not specify whether dismissal was with or without prejudice — a distinction with significant downstream consequences for Apotex’s ability to re-enter the ozanimod market and for BMS’s ability to reassert the same patent claims.

A 485-day resolution, ending before any trial or substantive merits ruling, is broadly consistent with a negotiated settlement or licensing arrangement in ANDA litigation, though the record is silent on any such terms. The involvement of both BMS and Receptos LLC as co-plaintiffs — reflecting the original patent assignment structure following BMS’s 2019 acquisition of Celgene, which had acquired Receptos — adds structural complexity to any licensing outcome. What drove early resolution, whether a consent judgment, a market-exclusivity agreement, or another commercial arrangement, remains undisclosed.